EpiCom : A Treatment Study of Tuberous Sclerosis Complex in Participants aged 2 to 18 years old

Summary

This study is for children age between 2 and 18 years who have tuberous sclerosis complex to take part in a 62 weeks long clinical research study. The primary purpose of this clinical
research study is to learn more about behavioral challenges and other non-seizure symptoms in patients with tuberous sclerosis complex who start EPID(I/Y)OLEX (an investigational study medicine) as add-on therapy for their seizures. Individuals will be evaluated to determine their eligibility to participate in this study. Each patient who
qualifies will receive the investigational medication, as well as study-related medical exams and study-related laboratory tests, at no cost. Compensation for time and travel may also, be available.


Eligibility

Currently recruiting participants: Yes

Eligible gender: Male, Female

Eligible ages: 2 to 18

Inclusion criteria:

You or your child may be eligible to participate in this trial if you or your child

- 2 to 18 years of age
- Has a confirmed clinical diagnosis of Tuberous sclerosis complex with a history of seizures.

Doctors will also evaluate other criteria to make sure you and your child qualify for the study.

Exclusion criteria:

You or your child may not be eligible to participate in this trial if you or your child:
- Is currently pregnant, or breast feeding.
- Has a clinically significant unstable medical condition
- Currently enrolled in a clinical study

Participate

Fill out the following form if you want to participate in this research

Method of contact

Collection of personal information
Your personal information is collected under the authority of section 33(c) of the Freedom of Information and Protection of Privacy Act. If you have any questions about the collection or use of this information, please visit our Access to Information page.

Additional information

Contact information

Please contact Dr. Julia Jacobs-LeVan at 4039552480 or Julia.Jacobs- LeVan@albertahealthservices.ca

Principal investigator:

Julia Jacobs-Levan

Clinical trial:

Yes

REB-ID:

REB23-1683